Not Yet RecruitingPhase 4

Oral Nifedipine Versus Placebo for Pain and Healing After Hemorrhoidectomy

Yemen100 participantsStarted 2026-08-01

Plain-language summary

The goal of this clinical trial is to evaluate whether oral nifedipine reduces postoperative pain and improves wound healing after hemorrhoidectomy in adult patients aged 18-65 years undergoing elective surgery for grade III or IV hemorrhoids in Sana'a, Yemen. The main questions it aims to answer are: * Does oral nifedipine 20 mg twice daily for 14 days reduce postoperative pain compared with placebo? * Does oral nifedipine improve wound healing progression and shorten time to complete healing compared with placebo? Researchers will compare the nifedipine group to the placebo group to see if there is a significant reduction in pain scores, faster wound healing, lower analgesic consumption, and fewer complications. Participants will: * Take either oral nifedipine 20 mg or an identical-looking placebo capsule twice daily for 14 consecutive days, starting 6 hours after surgery. * Report pain intensity using a standard 0-10 Visual Analogue Scale at multiple time points during the first 28 days. * Attend follow-up visits on postoperative days 7, 14, and 28 for wound healing assessment and safety monitoring. * Use rescue analgesia (paracetamol and/or diclofenac) as needed for breakthrough pain.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients aged 18-65 years * Scheduled for elective hemorrhoidectomy for grade III or IV hemorrhoids * Ability to provide written informed consent * Ability to understand and complete study questionnaires * Willingness to comply with the study protocol and follow-up visits Exclusion Criteria: * Known hypersensitivity to nifedipine * Severe cardiovascular disease (unstable angina, recent myocardial infarction, severe heart failure) * Hypotension (systolic blood pressure \< 90 mmHg) * Severe hepatic or renal impairment * Pregnancy or breastfeeding * Current use of calcium channel blockers or nitrates * Emergency hemorrhoidectomy * Concurrent inflammatory bowel disease * History of anorectal surgery within the past 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale (VAS) Pain Score

Timeframe: Day 1, Day 2, Day 3, Day 7, Day 14, Day 28

Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) Score

Timeframe: Day 7, Day 14, Day 28

Time to Complete Wound Healing

Timeframe: Up to Day 28 (censored if not healed by Day 28)

Trial details

NCT IDNCT07659665

SponsorSana'a University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Dr. Kholood Ahmed AL-Subari, M.B.B.Ch

+967772729669 drkholooda@gmail.com

View on ClinicalTrials.gov More Hemorrhoids trials